NuvaRing Risks and Warnings Get Traction

I went to the NuvaRing Web site to see how Merck had dealt with what was clearly well-documented risk. I found the usual disclaimers and warnings regarding heart attacks, strokes, and smoking. I read, “The risk of getting blood clots may be greater with the type of progestin in NuvaRing than with some other progestins in certain low-dose birth control pills.” What did Merck mean by saying the risk “may be greater”? Would a young woman use NuvaRing if she knew that the F.D.A. had come up with an increased risk of 56 percent? The number of women affected appeared to be in the thousands, and there were millions of users. [Vanity Fair, January 2014]

THE CONTROVERSY over the side effects of Merck’s NuvaRing is breaking through in media stories that depict horrible tragedy and death, as class action lawsuits grow. Vanity Fair covers NuvaRing in their January issue, with Huffington Post having a piece on it today that includes Rep. Slaughter’s involvement in trying to get the F.D.A. to demand stronger labeling warnings for NuvaRing.

Having spent the majority of my life single and sexually active, though my physical liberation came a lot later than most (which you’ll read all about in my new book), birth control was a primary focus of mine, as it is all girls of reproductive age. It was never easy.

Back in my twenties, my performance schedule in shows, coupled with training and classes, as well as auditions for commercials that were a primary source of income for me, made my days stressful and manic. These were also the days when I suffered chronic migraines that were debilitating at times, though the show always went on, sometimes in between hurling episodes and grabbing naps in dark rooms.

It meant that the Pill was off limits for me, because the warning of possible stroke was real for serious migraine sufferers (of which I long ago cured myself). It’s one reason I finally chose the diaphragm, while also insisting my partner wear a condom, which always brought protestation. As regular readers know, these forms of contraception failed me, but celibacy wasn’t an option and isn’t for most girls, no matter your age.

What I’ve read on NuvaRing and other birth control options that rely on third-generation hormones set off all sorts of alarms for me. When Organon announced NuvaRing in 2002, it was seen as a women’s reproductive breakthrough, because it wasn’t a daily pill, but instead was inserted for three week periods, one week off, then it starts again, making contraception almost an afterthought.

But in one of the clinical trials for NuvaRing, a healthy woman in her 20s had developed a blood clot — a surprising occurrence that an investigator determined was probably related to the birth control device.

As a result, the FDA said Organon should include a statement in NuvaRing’s packaging insert specifically mentioning the clinical trial and warning women and health care providers that the ring might carry a higher risk of causing blood clots — formally known as venous thromboembolism, or VTE — compared with other hormonal contraceptives.

[“¦] An elevated VTE warning label would have been a huge blow. Such a warning might have discouraged women from using NuvaRing and made doctors less inclined to prescribe it — significantly cutting into the potential return on investment.

“We should really try to get it out of the text,” Wim Mens, from Organon’s regulatory affairs division at company headquarters in Oss, Netherlands, wrote to colleagues in an email in the fall of 2000. [“¦]

The Pill came with serious warnings at one time, but overall remains extremely safe. The decision I made on the Pill came quickly, because the side effects were immediate, in my case.

The I.U.D. is gaining with women again, after the initial Dalkon Shield IUD caused infections and even infertility. It also was only suggested for women who had finished having children. When I tried the I.U.D. I had massive cramping and spotting, which is still something women experience, as an article in the Wall Street Journal covers this week. They also report on new advances, including an easier insertion I.U.D.

NuvaRing utilizes a delivery method that can spike hormone levels, the risks in this not nearly understood well enough, with the numbers of women reporting VTE alarming, in my opinion. The warnings on the NuvaRing site are explicit, but the growing reports of very serious complications, including deaths, bring questions. The truth is that any time a drug or product comes on the market in America, see Vioxx, a gullible public presumes safety over risks that should be weighed, because patients often believe what they want to believe.

The comfy relationship between drug companies, the F.D.A., doctors, when combined with patients who want an easy fix to complex health issues, sometimes ends in collision.

“This is a pretty critical issue,” (Amy Allina, deputy director of the National Women’s Health Network) told HuffPost. “There are some methods, including some pills on the market, that have a slightly higher risk than others. If the woman is informed about it, she can weigh the risk for herself, and that’s why putting it in the label is so important.”

“You need to trust us with the information,” she added, emphasizing that the effort here was not to remove NuvaRing from the market but simply to explain the added risk to women and their health care providers.

[Huffington Post]

The Vanity Fair article focuses a great deal on the lawsuits against NuvaRing, with writer Marie Benner contacting Merck for a statement about the growing conversation over NuvaRing.

In the initial response to my e-mails and phone calls requesting an interview with Merck chairman Ken Frazier or one of the company lawyers, a pleasant Merck employee named Lainie Keller asked how the company could be helpful. When I explained that I was focusing only on NuvaRing, she said she understood magazine deadlines and would get back to me soon. Two days later, I received an e-mail from her. “Ken Frazier and our other colleagues are not available to participate in this opportunity,” she wrote, and she directed me to several Web sites, including ACOG’s and Merck’s, “to help provide perspective.” At the end of the e-mail, Keller included Merck’s official statement: “Blood clots have long been known as a risk associated with combined hormonal contraceptives. The FDA-approved patient information and physician package labeling for NuvaRing include this information. . . . We remain confident in the safety and efficacy profile of NuvaRing””which is supported by extensive scientific research””and we will continue to always act in the best interest of patients.”

There is no more coveted endorsement than “FDA-approved patient information” for a product. The fine print is where the fall out lies.